Merck and Schering-Plough officials overseeing the Enhance study saw a threat to Vytorin back in late 2005, the Wall Street Journal reports. Study participants were healthier than officials thought they would be--meaning that it could be harder for Vytorin to show its stuff. That's also when the companies spotted the "implausible" data previously cited as a reason for the long delay in making the study results public.
The WSJ turns up some other behind-the-scenes stuff in this preview to the study presentation at the American College of Cardiology meeting March 30. For instance, Merck and Schering-Plough brought in an outside research team to compete with the study's independent overseers on reading image data, then ended up taking the whole effort in-house. Dr. John Kastelein, the outside scientist who led the study, now says the data would have been made public months earlier if he'd had control of it.
The big questions Enhance has raised--questions likely to get bandied about with increasing intensity after the presentation--are these, the WSJ notes: How much control should sponsors have over clinical trials that influence doctors and regulators? And just how valuable are cholesterol-lowering drugs? Expect lots of chatter as the week wears on.
- read the WSJ article
- see the item in the WSJ Health Blog
- check out a nice background piece on Enhance and statin use in Forbes